BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111347320·DUAL HEAD STETH 22" Y-TUBE GRY

    NEUROEDGE INFUSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APPLIANCE, FIXATION, NAIL

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KTT·August 18, 2015

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·February 28, 2023

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·February 19, 2026

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 16, 2013

    FREESTYLE NAVIGATOR

    FDA Adverse Event
    Malfunction ·Product code MDS·April 18, 2011

    ACCU-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·June 17, 2008

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024